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Recruiting NCT06205160

Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

No phase Interventional Focal Epilepsy Intraoperative Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SOFT ECoG subdural grid electrode.
Who it may be relevant to
Registry conditions: Focal Epilepsy, Intraoperative Monitoring. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery

Overview

The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery. Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.

Interventions

  • Device SOFT ECoG subdural grid electrode
    Test Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection. All procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marke

Primary outcome measures

  • Background SNR pre-resection recording [Time frame: up to 24 hours]
Secondary outcome measures (5)
  • Electrode deficiency ratio (%) [Time frame: up to 24 hours]
  • Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR) [Time frame: up to 24 hours]
  • Background SNR of post-resection recordings [Time frame: up to 24 hours]
  • Surgical complications (e.g. SAEs/SADEs) [Time frame: up to hospital discharge, on average at 10 days]
  • Usability evaluation [Time frame: up to 48 hours]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years at the time of enrolment
  • Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
  • Provided informed consent for study participation by the subject

Exclusion criteria

  • Occipital lesion
  • Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
  • Planned ioECoG recordings during fully awake surgery and/or functional recordings
  • Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
  • Active participation in another investigational device study
  • Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
  • Insufficient understanding of Dutch language.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • University Medical Center (UMC) Utrecht — Utrecht

Identifiers

NCT: NCT06205160 · CIP-01202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗